NCT02220920

Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

Detailed description

This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Canagliflozin (TA-7284)	The patients will receive Canagliflozin orally for 16 weeks
DRUG	Placebo	The patients will receive Placebo orally for 16 weeks
DRUG	Insulin

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-08-20
• Last updated: 2026-01-08
• Results posted: 2016-12-15

Locations

7 sites across 1 country: Japan